Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00362492
NCT00362492CompletedPhase 4

9-10 Days Versus Prolonged Thromboprophylaxis in Patients Without Evidence of Ultrasound Proximal Thromboembolism After Total Knee Joint Replacement: a Randomized Controlled Trial

University Hospital, Caen32 sites in 1 country850 target enrollmentStarted: June 2004Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
850
Locations
32
Primary Endpoint
Thromboembolism occuring between day 7-35 ;
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to determine whether stopping Low Molecular Weight Heparin (LMWH) thromboprophylaxis is safe after total knee joint replacement. The investigators select patients without proximal thromboembolism assessed by bilateral venous ultrasound examination 7-10 days after surgery. the investigators hypothesis is that stopping thromboprophylaxis is equally effective than prolonging thromboprophylaxis in order to prevent post-surgery complications in this population.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
46 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •First total knee joint replacement
  • •Signed informed consent
  • •Non-inclusion Criteria:
  • •History of venous thromboembolism/major bleeding/Heparin induced thrombopenia
  • •Active cancer
  • •Long-term anticoagulation

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Thromboembolism occuring between day 7-35 ;

Major bleeding occuring between day 7-35 ;

LMWH induced thrombopenia

All cause mortality

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (32)

Loading locations...

Similar Trials

Completed
Phase 3
PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)Critical IllnessDeep Venous Thrombosis
NCT00182143McMaster University3,659
Unknown
Phase 4
Two Weeks of Low Molecular Weight Heparin for Distal Vein ThrombosisPulmonary EmbolismVenous Thrombosis
NCT01252420Monash Medical Centre330
Unknown
Phase 3
ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS AFTER LAPAROSCOPIC SURGERY FOR COLORECTAL CANCER.The Primary Study Objective is to Assess the Efficacy andSafety of Extended 4-week Heparin Prophylaxis Compared toProphylaxis Given for 8±2 Days After Planned LaparoscopicSurgery for Colorectal Cancer.The Clinical Benefit Will be Evaluated as the Difference inthe Incidence of VTE or VTE-related Death Occurring Within 30 DaysFrom Surgery in the Two Study Groups.
NCT01589146University Of Perugia400
Terminated
Not Applicable
LMWH to Prevent Preeclampsia and Fetal Growth RestrictionPreeclampsia
NCT00260520University of Florence
Unknown
Not Applicable
Low-Molecular-Weight Heparin (LMWH) for Deep Venous Thrombosis (DVT) ProphylaxisDeep Venous Thrombosis
NCT01029821University of Tennessee100